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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K914187
Device Name AMBU SILICONE RESUSCITATOR INFANT/CHILD
Applicant
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090 -1356
Applicant Contact DAVID LEE
Correspondent
Ambu, Inc.
611 N. Hammonds Ferry Rd.
Linthicum,  MD  21090 -1356
Correspondent Contact DAVID LEE
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/18/1991
Decision Date 10/07/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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